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Ingenol Mebutate


General


Pronunciation

(IN je nol MEB u tate)


Brand Names: U.S.

  • Picato

Indications


Use: Labeled Indications

Actinic keratosis: Topical treatment of actinic keratosis


Contraindications


Hypersensitivity to ingenol mebutate or any component of the formulation.


Dosing and Administration


Dosing: Adult

Actinic keratosis: Topical:

Face or scalp: Apply 0.015% gel once daily to affected area for 3 consecutive days; patients not achieving clearance or that experience recurrence after achieving clearance ≥8 weeks after initial treatment may benefit from a second treatment course.

Trunk or extremities: Apply 0.05% gel once daily to affected area for 2 consecutive days


Dosing: Geriatric

Refer to adult dosing.


Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturers labeling. However, dosage adjustment unlikely due to low systemic absorption.


Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturers labeling. However, dosage adjustment unlikely due to low systemic absorption.


Administration

Apply topically to one contiguous affected area of skin using one unit-dose tube; one unit-dose tube will cover ~5 cm x 5 cm (~25 cm2 or ~2 inch x 2 inch). Spread evenly then allow gel to dry for 15 minutes. Do not cover with bandages or occlusive dressings. Wash hands immediately after applying and avoid transferring gel to any other areas. Avoid washing or touching the treatment area for at least 6 hours, and following this period of time, patients may wash the area with a mild soap. Not for oral, ophthalmic, or intravaginal use. Avoid application near or around the mouth and lips. Avoid transfer of gel to the periocular area.


Storage

Store in a refrigerator at 2 ‚ °C to 8 ‚ °C (36 ‚ °F to 46 ‚ °F); excursions are permitted to 0 ‚ °C to 15 ‚ °C (32 ‚ °F to 59 ‚ °F); do not freeze. Discard tubes after single use.


Dosage Forms/Strengths


Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, External:

Picato: 0.015% (3 ea); 0.05% (2 ea) [contains benzyl alcohol, isopropyl alcohol]


Drug Interactions

There are no known significant interactions.


Adverse Reactions


Frequency not always defined. Percentages represent face/scalp and trunk/extremities incidences unless otherwise specified.

Central nervous system: Headache (face/scalp: 2%)

Dermatologic: Erythema (92% to 94%; grade 4: 15% to 24%), desquamation ( ≤90%; grade 4: ≤9%), exfoliation of skin ( ≤90%; grade 4: ≤9%), crusted skin (74% to 80%; grade 4: 4% to 6%), swelling of skin (face/scalp: 79%; trunk/extremities: 64%; grade 4 [both indications]: 3% to 5%), localized vesiculation (face/scalp: ≤56%, grade 4: ≤5%; trunk/extremities: ≤44%, grade 4: ≤1%), local pustules (face/scalp: ≤56%, grade 4: ≤5; trunk/extremities: ≤44%, grade 4: ≤1%), dermal ulcer ( ≤32%; grade 4, trunk/extremities: ≤1%), skin erosion ( ≤32%; grade 4, trunk/extremities: ≤1%), application site pain (face/scalp: 15%, trunk/extremities: 2%), application site pruritus (8%), application site irritation (trunk/extremities: 4%), skin infection (face/scalp: 3%; at application site)

Ophthalmic: Periorbital edema (face/scalp: 3%), conjunctivitis, eyelid edema, eye pain

Respiratory: Nasopharyngitis (trunk/extremities: 2%)

<1% (Limited to important or life-threatening): Anaphylaxis, conjunctivitis (chemical-induced), corneal injury (burn), eye injury (FDA Safety Alert, August 21, 2015), herpes zoster, severe hypersensitivity (includes allergic contact dermatitis)


Warnings/Precautions


Concerns related to adverse effects:

- Dermatologic reactions: Severe reactions including erythema, crusting, swelling, vesiculation/pustulation, and erosion/ulceration can occur.

- Hypersensitivity: Cases of hypersensitivity, including anaphylaxis and allergic contact dermatitis, have been reported. If anaphylaxis or other clinically significant hypersensitivity reaction occurs, discontinue immediately and manage as appropriate.

- Ocular: Avoid treatment in the periocular area. Severe eye pain, chemical conjunctivitis, corneal burning, eyelid edema, eyelid ptosis, and periorbital edema can occur after exposure. Patients should wash their hands immediately after applying and avoid transferring to the eye area. If accidental exposure occurs, patient should flush area with water and contact health care provider.

Other warnings/precautions:

- Appropriate use: Apply to intact and nonirritated skin only. Instruct patients to wash hands well after applying and to avoid contact with the periocular area during and after application. Avoid touching the treated area for 6 hours after application. If inadvertent exposure to other area(s) occurs, flush the area with water and seek medical care as soon as possible. Avoid inadvertent transfer to other individuals. Administration of ingenol mebutate gel is not recommended until the skin is healed from any previous drug or surgical treatment. For topical use only; not for oral, ophthalmic, or intravaginal use.


Pregnancy Risk Factor

C


Pregnancy Considerations

Adverse events were observed in some animal reproduction studies following IV administration of ingenol mebutate. Absorption is limited in humans following topical application.


Actions


Pharmacology

Ingenol mebutate appears to induce primary necrosis of actinic keratosis with a subsequent neutrophil-mediated inflammatory response with antibody-dependent cytotoxicity of residual disease cells; killing residual disease cells may prevent future relapse (Ramsay 2011; Siller 2010).


Absorption

Absorption through the skin is minimal (with proper use); expected systemic exposure is <0.1 ng/mL.


Patient and Family Education


Patient Education

- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Patient may experience skin crusting, scaling, flaking, redness, or edema; headache; rhinitis; or pharyngitis. Have patient report immediately to prescriber signs of skin infection, skin ulcers, severe skin reaction or irritation, dizziness, or passing out (HCAHPS).

- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating, and advising patients.

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